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H.R. 7248 · 118th Congress

FDA Modernization Act 3.0

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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

BCR CarterSponsor
46 cosponsors · 24 D, 22 R

This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals.

What it does: CRS summary · Introduced in House · Feb 6, 2024

FDA Modernization Act 3.0

This bill requires the Food and Drug Administration (FDA) to establish a process that supports nonclinical testing methods for drug development that do not involve the use of animals.

Specifically, the FDA must establish a pathway by which entities may apply to have nonclinical testing methods approved for use in a particular context. Qualifying methods must be intended to replace or reduce animal testing and to either improve the safety and efficacy of nonclinical testing or reduce the time to develop a drug. The FDA must issue its decision within 180 days of receiving an application. The FDA must also prioritize the review of applications for drugs that are developed using an approved nonclinical testing method.

The FDA must annually post a report on its website that summarizes the results of the bill's implementation, including the number of applications received, types of methods that were approved, and the estimated number of animals saved as result of these methods.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: FDA Modernization Act 3.0

Latest action (Feb 9, 2024): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Feb 6, 2024

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.